Erwinase 10.000 ui polvo para solucion inyectable y para perfusion

Prospect: information for the patient

Erwinase 10000U powder for injectable solution and for infusion.

Crisantaspasa (L-asparaginase fromErwinia chrysanthemi)

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

6.Contents of the package and additional information

How Erwinase works

This medication is a treatment for blood cell cancers and belongs to a group of medications known as “antineoplastics and immunomodulators”. It acts by reducing the level of asparagine (an amino acid) in your body. Asparagine is a substance that cancerous cells need to survive.

What Erwinase is used for

This medication is mainly used in children, for the treatment of white blood cell cancer (acute lymphoblastic leukemia), in patients who have experienced an allergic reaction to other similar medications.

This medication is used in conjunction with other treatments.

Do not take Erwinase:

• If you have had a severe allergic reaction (hypersensitivity) to the active ingredient (crisantaspase) or if you are allergic to any of the other components of this medication. You can find these substances in section6.
• If you have severe liver failure.
• If you have or have had severe pancreas problems (acute pancreatitis) caused by a medication containing L-asparaginase.
• If you have pancreatitis not related to L-asparaginase.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

• This medication should only be used by doctors who are specialized in this type of treatment.
• Severe allergic reactions that can be fatal have been reported. If you experience a reaction to the treatment, the hospital will need special medications and equipment to treat you.
• Your body may become sensitive to the active ingredient after repeating the treatment.
• If you experience abdominal pain, it may be a symptom of pancreatitis (inflammation of the pancreas) and you should inform your doctor immediately. Pancreatitis can be fatal.
• You may have too much sugar in your blood (hyperglycemia) during treatment. This can be treated with insulin administration.
• During treatment, your body may be less able to prevent severe bleeding. If you suffer a severe bleeding, treatment will be stopped. The doctor will determine if treatment is started again and when.
• The use of this medication may cause or worsen reduced liver function. The doctor will consider stopping treatment in case of a severe reaction. Treatment may be resumed under strict observation, but only when you have recovered sufficiently.
• If the doctor or nurse spills this medication on you or themselves, especially in the eyes, that part of the body should be washed with plenty of water for 15 minutes.
• Severe neurological disorders (nervous system disorders) with fatal outcome have been reported. The posterior reversible encephalopathy syndrome (characterized by headache, confusion, seizures, and loss of vision) may require treatment with medications to lower blood pressure and, in the case of seizures, the use of antiepileptics.
• The destruction of cancer cells produces high levels of uric acid (a residual substance) in the blood. This can reduce kidney function.
• Immune system weakening has been observed during treatment with this medication. This may make you more susceptible to infection.

Blood and urine analysis

During treatment, your doctor will perform regular blood and urine tests to detect possible adverse effects, such as:

• Allergic reactions
• If your pancreas, kidneys, and liver are functioning correctly.
• If you have enough blood cells left.

For reasons of traceability, the healthcare professional will record the name of the product and the batch number of each dose of Erwinase you receive.

Other medications and Erwinase

• Since Erwinase can affect liver function and blood enzyme and protein levels, it may alter the functioning of medications that are sensitive to these.
• Erwinase may increase the activity or damage caused by other chemotherapy medications (cancer treatment medications). This applies especially to the following chemotherapy medications: methotrexate, cytarabine, vincristine, imatinib, and prednisone (a corticosteroid).
• Occasionally, allopurinol, a medication for gout (a painful inflammatory condition), must be administered to protect the kidneys.

Erwinase should not be mixed with other medications before administration.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• If you are pregnant, you should not use this medication unless it is absolutely necessary. Inform your doctor immediately if you become pregnant during treatment with this medication or if you plan to become pregnant in the near future.
• You should not breastfeed during treatment with this medication.

Fertility and family planning

The possibility of a negative impact on male fertility cannot be ruled out.

Both men and women should use contraceptive methods before and during some time after treatment with Erwinase.

Driving and operating machinery

When driving and operating machinery, you should be aware of the reduced reaction time, nausea, and vomiting.

Erwinase contains sodium

This medication contains sodium, less than 1mmol (23mg) per dose; this is essentially “sodium-free”.

Dosage

The doctor will calculate your body surface area in square meters (m²) and use it to determine the dose you should receive.

Normally, the doctor will treat you with 25,000 U of Erwinase per square meter.

The amount you receive may change and will depend on the amount of asparaginase (the active ingredient in this medication) in the blood, which can be checked during treatment.

Administration form

This medication will be administered in one of the following ways:

a) Through a vein by infusion (intravenous route).

b) In a muscle by injection (intramuscular route).

This medication should be administered by your doctor or nurse by injection or infusion. Before the injection or infusion, the powder is dissolved very precisely (in saline solution).

Normally, treatment is administered without interruptions. If it is necessary to stop treatment, it can be resumed at a lower dose.

Treatment duration

You will receive an injection three times a week for two weeks. This may change, depending on new clinical study results.

If you have received moreErwinasethan you should

If you think you have received more Erwinase than you should, contact your doctor or another healthcare professional immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you did not receive this medication

If you think you did not receive a dose, contact your doctor or another healthcare professional immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects listed below have been observed when this medicine was administered with other cancer treatment.

This medicine will be administered under strict medical supervision, and your doctor may prescribe other medicines to treat these side effects. Most side effects will disappear as soon as you stop taking this medicine.

Consult a doctor immediatelyif you experience any of the following side effects:

Consult a doctor immediatelyif you experience any of the following side effects:

Very frequent (affect more than 1 in 10 people)

Frequent (affect less than 1 in 10 people)

Rare (affect less than 1 in 100 people)

Rare (affect less than 1 in 10,000 people)

Very rare (affect less than 1 in 10,000 people)

Frequency unknown (cannot be estimated from available data)

Most side effects are reversible (disappear once you stop taking the medicine).

Other side effects in children and young adults

The side effects affecting the liver, pancreas, and blood clotting are more frequent in adults than in children and young adults.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

The hospital will store this medication in a refrigerator (between 2°C and 8°C) and it should not be used after the expiration date, which appears on the packaging after “CAD”. The expiration date is indicated by the month and year. The expiration date is the last day of the month indicated.

Composition of this medication

• The active principle of this medication is L-asparaginase fromErwinia chrysanthemi.
• Each vial contains 10,000 U (units) of L-asparaginase.
• The other components are sodium chloride, monohydrated glucose, sodium hydroxide, acetic acid

Appearance of Erwinase and contents of the packaging

Erwinase is a white powder contained in a small glass vial.

Each package contains 5 small glass vials.

Marketing Authorization Holder

Porton Biopharma Limited

Lee View House, 13 South Terrace

Cork, T12 T0CT

Ireland

Phone:+44 1980 745 022

Email: medinfo@portonbiopharma.com

Responsible for manufacturing

Almac Pharma Services Limited

Seagoe Industrial Estate

Portadown, Craigavon

BT63 5UA

United Kingdom (Northern Ireland)

This medication has been authorized in the Member States of the EEA under the following denominations:

Austria, Belgium, Finland, France, Germany, Ireland, Netherlands, Poland, Portugal:Erwinase

Last review date of this leaflet:March 2022

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

SEPARATE HERE AND GIVE INSTRUCTIONS TO THE PATIENT

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This information is intended solely for healthcare professionals:

The contents of each vial must be reconstituted with 1 ml or 2 ml of 0.9% sodium chloride injectable solution.

Add the sodium chloride injectable solution slowly to the inner wall of the vial, do not add it directly above or inside the powder. Dissolve the contents by mixing or gently rotating the vial while keeping it in a vertical position. Avoid contact between the solution and the stopper. Avoid foam formation by agitating it too much or with force.

The solution must be transparent, without visible particles. If it is agitated too much and foam is visible, fine filamentous or crystalline protein aggregates may be observed. If there are visible particles or protein aggregates, the reconstituted solution must be rejected.

The reconstituted injectable solution must be administered within 15 minutes of reconstitution. If it is unavoidable that more than 15 minutes pass between reconstitution and administration, the solution must be extracted with a sterile glass or polypropylene syringe in sterile conditions. The syringe containing the reconstituted solution must then be stored below 25°C and used within 4 hours.

To administer IV, it is recommended to dilute the reconstituted Erwinase solution in 100 ml of 0.9% sodium chloride solution. To facilitate preparation, the reconstituted Erwinase solution can be transferred directly to the pre-loaded bag with 100 ml of 0.9% sodium chloride solution for IV administration.

It is recommended to use the diluted IV solution immediately after preparation. If not used immediately, the IV solution can be stored in a PVC chloride bag. The IV bag must be stored below 25°C and used within 4 hours.

From a microbiological point of view, the reconstituted injectable solution must be used immediately, unless the reconstitution method eliminates the risk of microbial contamination. If not used immediately, the user is responsible for the time and storage conditions.

Erwinase is a non-cytotoxic medication and does not require special precautions for handling these types of medications. However, when preparing or administering Erwinase, it should be noted that it may be sensitizing.

Avoid inhaling the powder or solution. In case it comes into contact with the skin or mucous membranes, especially the eyes, it must be rinsed with abundant water for at least 15 minutes.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

In the absence of compatibility studies, this medication should not be mixed with others. Consequently, other intravenous medications should not be administered through the same intravenous route as Erwinase.